ABSTRACT

(1) Modafinil, a psychostimulant, has been available in France for the treatment of narcolepsy and idiopathic hypersomnia since 1994. (2) The initial clinical file was inadequate to judge its possible clinical value. (3) In narcolepsy three new short-term clinical trials have compared modafinil with a placebo (nearly 500 patients treated with modafinil). (4) These trials show that the effects of modafinil on daytime drowsiness are only moderate (average reduction of one unwanted sleep episode a day) but are subjectively better than those of a placebo. In all, 84% of patients preferred the modafinil period to the placebo period during a cross-over trial. In contrast, modafinil does not improve cataplexy. (5) No new trials have been done in idiopathic hypersomnia. (6) The effects of modafinil persist for at least four months according to a double-blind placebo-controlled trial. (7) The safety profile of modafinil appears to be similar to that of non amphetamine psychostimulants. (8) There is currently no evidence of dependence leading to withdrawal symptoms after abrupt treatment cessation, or of a risk of abuse.